Regulatory Affairs Associate Specialist, International Labeling Support

About the role

The Associate Specialist, International Labeling Support (ILS) supports cross-functional collaboration within GRACS and, where applicable, across divisions, so that labeling and artwork regulatory activities are planned, coordinated and executed in a timely, accurate and compliant way. The role covers routine operational work, issue resolution under guidance and process improvement.

Key responsibilities

• Support the preparation of high-quality labeling and artwork packages and provide routine operational support to Country Regulatory Affairs, such as database maintenance and record filing.
• Engage with Global Labeling and Country/Regional Regulatory Affairs on labeling and artwork queries, with guidance from more experienced colleagues.
• Assist with process documentation updates and periodic revisions, and contribute to process improvement initiatives.
• Follow up on key milestones (such as HA submissions and approvals) and prepare escalation information for senior team members.
• Collect country inputs and requirements with Country Regulatory Affairs to plan and execute labeling and artwork processes.
• Support cross-functional projects, such as CMC changes, artwork preparation for launches and liaison with Country Regulatory Affairs.

Required profile

• Bachelor's degree or equivalent experience in life sciences, pharmacy, regulatory affairs, business or a related field.
• Entry-level profile: previous internship, apprenticeship or up to 1 year of experience in the pharmaceutical industry, regulatory affairs, quality, supply chain or another regulated environment is desirable.
• Basic awareness of regulatory affairs, labeling, artwork, quality, compliance or pharmaceutical operations, with a willingness to learn.
• Ability to work respectfully in a matrix and multicultural environment with support from more experienced colleagues.
• Good organization, attention to detail, clear written and verbal communication, and basic proficiency with Microsoft 365 apps (Outlook, Excel, PowerPoint, Teams, SharePoint).